drugset / Trial / NCT01334515
Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-12-31
- Completion
- 2019-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isotretinoin | Other / unclassified | — | Oral |
| Subject | hu14.18-IL2 fusion protein | Protein / enzyme biologic | — | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | — | Subcutaneous |